MAUDE Adverse Event Report: BD BD VERITOR PLUS SYSTEM; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number PLUS SYSTEM

Device Problem False Negative Result (1225)

Patient Problems Fever (1858); Headache (1880); Cough (4457)

Event Date 10/29/2020

Event Type  malfunction  

Event Description

The rapid/poc test was negative on (b)(6) 2020 using bd veritor plus system via nasopharyngeal swab.A pcr/molecular nasopharyngeal swab was done at the same time and sent to mako laboratories; we received a call on 10/31/2020 stating the pcr was positive.Staff member left work due to symptom onset of headache, scratchy throat, and cough.Forehead temp 99.4 degrees.Therapy start date: (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: BD VERITOR PLUS SYSTEM
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BD; waycross GA 31503
• MDR Report Key: 10791607
• MDR Text Key: 215024335
• Report Number: MW5097650
• Device Sequence Number: 1
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: PLUS SYSTEM
• Device Catalogue Number: 256066
• Device Lot Number: JB202303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 181